The proportion of outpatient High Dose Methotrexate courses which result in an inpatient hospital admission. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Patients will be evaluated prior to and daily during each outpatient HDMTX course, and if one or more of a list of hospitalization criteria are met, the patient will be admitted to hospital to complete that course.

Secondary Outcome Measures:

The institutional costs for all the inpatient courses which occur on study [ Time Frame: 2 years ] [ Designated as safety issue: No ]

The average cost of an outpatient course [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Patient and parent satisfaction [ Time Frame: After the first outpatient course (Day 4 or 5 (anticipated)) and at the end of participation in the study (up to 10 months) ] [ Designated as safety issue: No ]

The tool will utilize a 5 point visual analog scale and include assessments of the following items: home medication administration, measuring urine pH, pump/supplies, MD support, education and instruction. Any score ≥ 3 will be considered as 'satisfied'.

This is a single arm study. All subjects enrolled in the study will be in this arm.

Drug: High Dose Methotrexate

Methotrexate will be given by IV at a dose of 12 gram/m2/dose.

The patient will receive 4-6 hours of hydration with alkalinization, and then HD MTX will be infused over 4 hours. Following this, the patient will be discharged home to receive continuous intravenous hydration through a portable pump. The patient will return to hospital daily for a comprehensive clinical assessment, IV hydration and antiemetics, MTX level and creatinine monitoring until MTX is cleared (3-4 days).

Detailed Description:

High Dose Methotrexate (HDMTX) is an integral part of osteosarcoma therapy whose main toxicities include myelosuppression, mucositis, nephrotoxicity, and hepatitis. In order to deliver HDMTX therapy safely, patients require urinary alkalinization, hydration, monitoring of renal function, therapeutic drug monitoring, and leucovorin rescue. Due to the required supportive care needs, HDMTX has historically been given as an inpatient. In some centers however, HDMTX is being given safely as an outpatient in order to reduce health care costs, improve patient quality of life and to deliver timely therapy with limited inpatient chemotherapy beds available.

Parent and/or patient must be able to provide written consent, and complete Patient Flow Sheets in English.

Exclusion Criteria:

Patients, in the opinion of the primary healthcare team, may not be able to comply with the safety monitoring requirements of the study, or in whom compliance is likely to be suboptimal.

Pregnant females

Breastfeeding females

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01176981